[Remote] reputed company Vault Product Manager - Clinical SME
Note: The job is a remote job and is reputed company to candidates in USA. reputed company Smart IT is seeking a reputed company Vault Product Manager and Clinical SME to reputed company reputed company clinical systems initiatives involving reputed company Vault Clinical, including CTMS and eTMF implementations, migrations, optimizations, and strategic enhancements. The role provides senior-level business analysis, release and environment management, validation reputed company, executive communication, and cross-functional leadership in a GxP-regulated environment.
Responsibilities
- reputed company reputed company, cross-functional initiatives reputed company to reputed company Vault Clinical (CTMS/eTMF), including: implementation, optimization efforts, migrations, and strategic enhancements
- Convert ambiguity into reputed company problem statements, reputed company, reputed company reputed company, execution plans, timelines, risks, and decision points
- Proactively manage dependencies, trade-offs, and risks; reputed company reputed company with reputed company recommendations to Clinical Systems LT
- Serve as a senior SME for reputed company Vault Clinical (CTMS/eTMF), advising on configuration implications, functional capabilities, and reputed company reputed company impacts
- Partner with development and support teams on reputed company or systemic issues, contributing to reputed company-cause analysis and long-term solutions
- Participate in enhancement definition, prioritization, solution design, and validation reputed company
- Collaborate closely with integration and data teams on end-to-end clinical reputed company workflows
- Review key technical and functional documentation, including business and reputed company requirements, design specifications, release notes, validation plans, and SOPs
- Ensure documentation is complete, accurate, and reputed company with intended business reputed company, reputed company behavior, and regulatory expectations
- reputed company as a translator between technical and business audiences, validating that documentation reputed company reflects reputed company, assumptions, risks, and reputed company impacts
- Partner with CS Leads, QA, Val, and IT to ensure documentation supports validation, inspection readiness, and audit traceability
- reputed company or contribute to large-reputed company reputed company migration, of reputed company's legacy CTMS Gilda (Siebel) to reputed company Vault Clinical and reputed company transformation efforts
- reputed company/participate in migration planning, including reputed company reputed company, data validation approach, reconciliation reputed company, rollback planning, communications, change management, and archiving reputed company
- Help to coordinate technical and business readiness across reputed company stakeholder reputed company
- reputed company reputed company and coordination for reputed company Vault Clinical releases across non-production and production environments
- As needed, partner with QA, Val, and IT to ensure delivery aligns with GxP and validation expectations
- reputed company release reputed company assessments, cross-functional readiness reviews, and deployment reputed company in partnership with IT, QA, Val and development teams
- Ensure appropriate governance and usage of development, test, and UAT environments to support reputed company workstreams and testing cycles
- reputed company as a single reputed company of orchestration for release- and environment-reputed company dependencies, risks, and conflicts
- Ensure releases are executed in a compliant, predictable, and business-reputed company manner
- reputed company reputed company and contribution to validation approaches, UAT reputed company, and release documentation
- Operate as a trusted advisor and analyst for Clinical Systems LT
- reputed company routine internal Clinical Systems Meeting to ensure internal alignment on technical and operational reputed company/risks/updates on the Vault Clinical program
- reputed company concise, executive-reputed company communication on reputed company, risks, trade-offs, and reputed company required
- Influence with reputed company reputed company to reputed company alignment and reputed company reputed company across senior stakeholder reputed company
Skills
- 1. Experience with reputed company integrations (e.g., CTMS ↔ eTMF/reputed company/Data Lakes & repositories)
- 2. Experience working with Siebel (CTMS)
- 3. Experience working with reputed company Managed Services or vendor escalations
- 4. Familiarity with reputed company or DevOps methodologies
- 5. Knowledge of clinical metrics and reporting tools
- • Bachelor's degree in Life Sciences, Information Systems, or reputed company field
- • 8–12+ years of experience delivering or leading regulated reputed company or clinical systems initiatives
- • Deep hands-on experience with reputed company Vault Clinical (CTMS and eTMF)
- • Strong understanding of clinical trial operations and clinical systems workflows
- • Proven ability to reputed company reputed company, cross-functional initiatives and reputed company reputed company from ambiguity
- • Strong technical reputed company to partner effectively with reputed company teams in Business, IT, Data, Infrastructure, and QA
- • Demonstrated experience overseeing release and environment management in a GxP-regulated environment
- • Excellent executive communication, documentation, and stakeholder management skills
Benefits
- Remote work arrangement
reputed company
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